Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01059747
Status:
UNKNOWN
Last Update Posted:
2010-02-01
First Post:
2010-01-29
Brief Title:
Therapeutic Drug Monitoring and Pharmacogenomics Study of Methadone Therapy
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2010-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M0108
Brief Summary:
Addiction has been regarded as one of the most serious health and social problems in Taiwan and heroin is currently considered to be the major substance of abuse The most widely used treatment to date is methadone replacement therapy It is reported that to achieve a better clinical response and to avoid possible side effects the blood level of methadone should remain in a certain level However the blood level of methadone is mediated by various factors besides dosage Genetic variability in genes that encodes enzymes affecting methadone metabolism target receptors of methadone and drug-drug interaction by other medication patients take will all affect blood level Therefore therapeutic drug monitoring TDM and pharmacogenomic study is crucial for evaluating and predicting the clinical response cause of side effects or toxicity as well as studies on drug-drug interactions
This is a cross-sectional study in order to evaluate the relationship between methadone plasma level and clinical response in patients under methadone maintenance therapy and to identify optimal therapeutic thresholds HPLC will be used to analyze methadone and its metabolites Our hypothesis is that methadone plasma levels in patients who are responsive to methadone maintenance therapy are higher than level in non-responsive patients and higher plasma level leads to less severe withdrawal symptoms We will also test if an optimal minimal dosage exists among these patients In the meanwhile we will aim to test if methadone level and clinical response is correlated with different genetic polymorphism Candidate genes that involve in pharmacokinetic and pharmacodynamic process of methadone eg CYP3A4 CYP3A5 CYP2B6 ABCB1 opioid mu receptor and kappa receptor will be genotyped for these analyses
The results of this study will provide clinical information of methadone treatment and pharmacogenomic data in Taiwanese for clinicians to achieve a better treatment outcome
This is a cross-sectional study in order to evaluate the relationship between methadone plasma level and clinical response in patients under methadone maintenance therapy and to identify optimal therapeutic thresholds HPLC will be used to analyze methadone and its metabolites Our hypothesis is that methadone plasma levels in patients who are responsive to methadone maintenance therapy are higher than level in non-responsive patients and higher plasma level leads to less severe withdrawal symptoms We will also test if an optimal minimal dosage exists among these patients In the meanwhile we will aim to test if methadone level and clinical response is correlated with different genetic polymorphism Candidate genes that involve in pharmacokinetic and pharmacodynamic process of methadone eg CYP3A4 CYP3A5 CYP2B6 ABCB1 opioid mu receptor and kappa receptor will be genotyped for these analyses
The results of this study will provide clinical information of methadone treatment and pharmacogenomic data in Taiwanese for clinicians to achieve a better treatment outcome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None